中文摘要：

目的制备胰岛素固体脂质纳米粒（Ins-SLNs），考察其理化性质，并建立测定包封率的方法。方法通过复乳／溶剂扩散法制备Ins-SLNs，考察其形态、粒径分布、Zeta电位；通过改变pH，调节Zeta电位后，采用冷冻高速离心分离纳米粒与游离Ins的方法，测定Ins-SLNs的包封率。结果复乳法制备的Ins-SLNs在扫描电镜下均呈球形，分布均匀，平均粒径为114．7±4．68nm，Zeta电位为-54．36±2．04mV；包封率测定方法的线性范围为1．047～100．47μg·ml^-1，平均回收率为98．37％，RSD=1．02％；测得3批Ins-SLNs样品的平均包封率为97．78％。结论所用制备工艺简单，制得的纳米粒包封率较高；包封率的测定方法方便、灵敏、准确。

英文摘要：

OBJECTIVE To prepare Insulin - loaded solid lipid nanoparticles （ Ins - SLNs） and investigate characteristics of their physical chemical properties, also to establish an efficient method for entrapment efficiency determination. METHODS The Ins - SLNs were prepared using a water - in - oil - in - water （ W/O/W） emulsion solvent diffusion technique. The characteristics of the nanoparticles were studied in terms of morphology, particle size distribution, Zeta potential and encapsulation efficiency （EE） which was determined via uhracentrifugation after modulation of Zeta potential by changing pH - value of the system. RESULTS The Ins - SLNs observed under scanning electronmicroscopy （SEM） were mostly spherical in shape. The average size of Ins - SLNs was 114. 7 e 4. 68 nm while Zeta potential and average EE were -54. 36 ± 2. 04 mV and 97.78% , respectively. Also, the method for determination of entrapment efficiency showed a good linearity range from 1. 047 - 100. 47 μg·ml^-1 , with a satisfactory mean recovery of 98. 37% and the RSD was 1.02%. CONCLUSION Ins - SLNs with well - defined characteristics such as high EE could be prepared by W/ O/W approach and the entrapment efficiency determination method is convenient, sensitive and accurate for measurement of the EE of Ins - SLNs.